MAUDE Adverse Event Report: RESPIRONICS, INC. GARBIN EVO, LINDE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LD2110X23B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A garbin evo was returned to a third-party service center for service.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.The garbin evo was returned and evaluated by the third-party service center.The in-process device evaluation found a ventilator inoperative error code related to the machine flow sensor and a ventilator inoperative error code related to the therapy cpu in the error log.Evt_mach_flow_drift_high means the machine flow sensor drift above the specification (greater than 0.2lpm).The machine flow sensor needs replaced to address the issue.Evt_tpy_held_in_bm means the therapy cpu is still running in boot monitor software.The system board needs replaced to address the issue.Additionally, a non-reportable error code related to the motor controller was found in the error log.Evt_mcl_foc_shutdown means the motor controller has proceeded to the shutdown state due to an error with the motor.The blower needs replaced to address the issue.Also, a non-reportable error code related to sensor offset was found in the error log.Evt_drift_debug means sensor offset during drift calculation is too high.The system board needs replaced to address the issue.

• Brand Name: GARBIN EVO, LINDE
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24630181
• Report Number: 2518422-2026-009738
• Device Sequence Number: 12974951
• Product Code: CBK
• UDI-Device Identifier: 00606959057432
• UDI-Public: (01)00606959057432
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LD2110X23B
• Device Catalogue Number: LD2110X23B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown